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A Vaccine for Schistosomiasis, "SchistoShield"

Award Number: R44AI103983
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/01/2013
PERIOD OF PERFORMANCE END DATE: 02/28/2025

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A Vaccine for Schistosomiasis, "SchistoShield" - PROJECT SUMMARY Schistosomiasis is a major parasitic disease which could impact up to a billion people in 74 countries. Current control strategies rely primarily on anti-parasitic drugs alone (praziquantel) which has proven inadequate due to both reinfection and the inherent threat of drug resistance. We have developed a potent schistosomiasis vaccine, termed SchistoShield®, targeting a functionally important antigen (Sm-p80) formulated with a potent immune- stimulator (GLA-SE). SchistoShield® has been exhaustively tested in rodents, rabbits, and baboons and has exhibited protection at all parasitic life-cycle stages including larvae, worms, and egg laying, survival, and excretion. We are completing our Phase II SBIR grant research focused on manufacture, lyophilization, and fill/finish of the antigen and will be entering into three clinical trials (first an NIH funded Phase 1 human trial in the USA, and next two Phase 1b trials funded by the European union which will be performed in Burkina Faso and Madagascar in Africa) beginning in the first quarter of 2020. To support our upcoming trials, this Phase IIb grant will focus on studies required to ensure stability of the vaccine drug product (DP) for the duration of the trials as required by regulatory agencies. The research will include assessing long-term stability, formal shipping studies, and development of a sensitive potency assay suitable for later stage clinical development. The potency assay will include immunization into mice followed by antibody titers after a single injection. We will forcibly degrade our antigen using simulated real-life conditions and test the altered protein for retention of immunological function using our potency assay. The goal will be to identify which quality parameters are directly indicative of a loss of potency. At the end of these studies we will have our DP on stability, formal shipping methods identified, a sensitive potency assay developed, and have identified critical quality parameters of potency of the vaccine. All these studies are required in preparation for Phase 2 and 3 clinical trials and future licensure and deployment.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	PAI LIFE SCIENCES INC	1551 EASTLAKE AVE E STE 250	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	8	4/23/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	PAI LIFE SCIENCES INC	1616 EASTLAKE AVE E	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	8	3/28/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $506,495 )
2022	2022	PAI LIFE SCIENCES, INC.	1616 EASTLAKE AVE E STE 250	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	8	2/3/2022	NON-COMPETING CONTINUATION	$506,495
														Subtotal = $506,495

Issue Date FY: 2021 ( Subtotal = $506,495 )
2021	2021	PAI LIFE SCIENCES, INC.	1616 EASTLAKE AVE E STE 550	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	7	2/4/2021	NON-COMPETING CONTINUATION	$506,495
														Subtotal = $506,495

Issue Date FY: 2020 ( Subtotal = $706,627 )
2020	2020	PAI LIFE SCIENCES, INC.	1616 EASTLAKE AVE E STE 550	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	001	6	3/12/2020	COMPETING CONTINUATION	$706,627
2020	2018	PAI LIFE SCIENCES, INC.	1616 EASTLAKE AVE E STE 550	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	5	3/2/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $706,627

Issue Date FY: 2018 ( Subtotal = $1,288,089 )
2018	2018	PAI LIFE SCIENCES, INC.	1616 EASTLAKE AVE E STE 550	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	5	12/29/2017	NON-COMPETING CONTINUATION	$1,288,089
														Subtotal = $1,288,089

Issue Date FY: 2017 ( Subtotal = $1,380,664 )
2017	2017	PAI LIFE SCIENCES, INC.	1616 EASTLAKE AVE E STE 550	SEATTLE	WA	98102	KING	USA	Allergy and Infectious Diseases Research	000	4	12/30/2016	NON-COMPETING CONTINUATION	$1,380,664
														Subtotal = $1,380,664

Issue Date FY: 2016 ( Subtotal = $1,159,786 )
2016	2016	PROTEIN ADVANCES INC	1124 COLUMBIA STREET	POINEER SQUARE	WA	98104		USA	Allergy and Infectious Diseases Research	000	3	12/29/2015	COMPETING CONTINUATION	$1,159,786
														Subtotal = $1,159,786

Grand Total All Awards = $5,548,156

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A Vaccine for Schistosomiasis, "SchistoShield"

Award Number: R44AI103983

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/01/2013

PERIOD OF PERFORMANCE END DATE: 02/28/2025

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